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Guidance on Nonclinical Testing for Nicotine Products

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on inhaled nicotine product nonclinical testing.

Cleaning Method Deviations Could Impair Sigma Pump: Baxter

[ Price : $8.95]

FDA says Baxter is reminding customers that deviations from prescribed cleaning methods for Sigma Spectrum infusion pumps could hu...

Timely PSGs Can Spur ANDA Submissions: CDER Research

[ Price : $8.95]

CDER analyzes factors that contribute to an increased likelihood of ANDA submissions for NCE and non-NCE innovator drugs.

FDA Enhancements Sought for Model-Informed Drug Development

[ Price : $8.95]

FDA pitches a plan to enhance its Model-Informed Drug Development (MIDD) activities under the next iteration of its Prescription D...

FDA Inks Agreement with SomaLogic for Proteomics Study

[ Price : $8.95]

FDA signs a five-year agreement with SomaLogic to study using proteomics to identify biomarkers that may be useful in demonstratin...

Strained by Covid, CDRH Wants More MDUFA Money

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CDRH seeks a boost to its resources as it negotiates the reauthorization of the Medical Device User Fee Act (MDUFA) program, claim...

Med-Pharmx Selling Adulterated Animal Drugs: DoJ

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The Justice Department asks a California federal court for an injunction to prevent Med-Pharmx from manufacturing and distributing...

Orally Inhaled Nicotine Drug Product Nonclinical Testing

[ Price : $8.95]

FDA issues a guidance on nonclinical information to support the development and approval of orally inhaled nicotine-containing dru...

Praise for Nervous System Metastases Draft Guidance

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Four drug companies recommend technical changes to an FDA draft guidance on evaluating cancer drugs in patients with central nervo...

Guidance on Automated External Defibrillator Accessories

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Federal Register notice: FDA makes available a final guidance entitled Necessary Automated External Defibrillator Accessories: Pol...